MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GREENFIELD; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	43335
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown; therefore, date is approximated.
Event or Problem Description
A greenfield filter was implanted on (b)(6) 2015.On an unknown date it was noted there was a perforation.The filter was noted to be tilted.No further patient complications were reported.
Event or Problem Description
A greenfield filter was implanted on (b)(6) 2015.On an unknown date it was noted there was a perforation.The filter was noted to be tilted.No further patient complications were reported.It was further reported that on (b)(6) 2017 the patient had a ct of their abdomen.The imaging revealed that the abdominal vasculature demonstrates an ivc filter in place with the tip at the level of the renal veins.The ivc filter is tilted anteriorly with the apex abutting the anterior wall of the inferior vena cava.A posterior strut penetrates the posterior wall of the inferior vena cava and is embedded in the anterior aspect of the l3 vertebral body.This extends approximately 8 mm posterior to the posterior wall of the interior vena cava.No strut fracture is noted.

• Brand Name: GREENFIELD
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9837356
• Report Number: 2134265-2020-03284
• Device Sequence Number: 13778003
• Product Code: DTK
• UDI-Device Identifier: 08714729070276
• UDI-Public: 08714729070276
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K964284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0017042737
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR